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International Research Journal of Pharmacy and Pharmacology (ISSN: 2251-0176) Vol. 1(3) pp. 033-042, June 2011
Available online
Copyright © 2011 International Research Journals
Full Length Research Paper
Impact of a community pharmacist-based diabetes
management program on clinical outcomes measures
Lee Y.L1, Rosnani H2, Syed A.S.S3, Syed W.G4*, Yelly O.S5,6, Usman H.U7
Universiti Kebangsaan Malaysia, Jalan Raja Muda Abdul Aziz, 50300 Kuala Lumpur. Alcare Pharmacy Sdn Bhd, 107,
Jalan Temenggong, 75000 Malacca, 2 Department of Pharmacy, Faculty of Allied Health Sciences, Kuala Lumpur
Campus, 3 Dean, School of Pharmaceutical Sciences, Universiti Sains Malaysia (USM), 4 Lecturer, Discipline of Clinical
Pharmacy, USM, Faculty of Pharmacy, Andalas University, Padang 25163, Indonesia, Discipline of Clinical
Pharmacy, School of Pharmaceutical Sciences, Universiti Sains Malaysia, 11800 Penang, Malaysia, 7 Master Student,
School of Dental Sciences, Universiti Sains Malaysia.
Accepted 22 March 2011.
This is a prospective pre-post study which was carried out to assess the impact of a community
pharmacist-based diabetes management program on clinical outcomes measures. Forty seven
outpatients from the Government polyclinic were initially enrolled for this study but only 30 stayed
on till the end of the program which was for duration of 3 months. Subjects were followed-up on 4
visits, whereby the community pharmacist provided a structured, standardized diabetes education
program which involved counseling and education. Each session lasted about 1 hour on a one to
one basis. Lifestyle behaviours such as physical activities, smoking and alcohol consumption were
also evaluated. Compliance, awareness and also their knowledge on diabetes were assessed. A
Likert-type patient satisfaction survey was also conducted. At the end of the study, HbA1c was
significantly reduced by 1.2% (p< 0.001), post-prandial 2 hours blood glucose reduced by
3.34mmol/l (p< 0.001), total cholesterol decreased by 0.37mmol/l (p<0.016), systolic blood pressure
decreased by 9.1mmHg (p< 0.001), diastolic blood pressure decreased by 4.8mmHg (p<0.001).
Weight, BMI and waist circumference did not change significantly. There was a significant
improvement in the compliance score and the patients were satisfied with the outcome of the
program which showed better control of their diabetes. In conclusion, the community pharmacist
has made an impact on the clinical outcome measures of the diabetic patient who participated in the
Keywords: Diabetes, Disease Management, Pharmaceutical Care, Community Pharmacy
An estimated 190 million people are affected by
diabetes mellitus world-wide, with over 330 million
predicted to have the condition by 2025 (IDF 2004).
underestimate the extent of the problem, since up to 50
% of the population with diabetes are thought to remain
undiagnosed and therefore untreated (GonzalezClemente, 2003). The prevalence of type 2 diabetes
varies considerably in regions, from 1% in Vietnam to
30 % in Nauru. A significant observation is that
*Corresponding author Email:[email protected]
prevalence (and incidence) of this chronic disease is on
the increase. In Malaysia, the National Health Morbidity
Survey (NHMS) done in 1986 showed that the
prevalence of diabetes was 6.3%. The prevalence
increased to 8.3% in 1996 (NHMS 1996). In 2003, the
International Diabetes Federation (IDF) estimated the
prevalence of diabetes mellitus in Malaysia for adults
20 -79 years of age as 9.4% which is equivalent to 1.25
million diabetics. Estimates for the year 2025 for the
same age group is 12.1% or 2.6 million (Sicree, 2003).
Type 2 diabetes is a major cause of premature
morbidity and mortality, particularly from cardiovascular
diseases (CVDs), blindness, amputations and renal
failure. Thus, the management of type 2 diabetes must
Int. Res. J. Pharm. Pharmacol. 034
not only address the control of hyperglycaemia but also
the other CVD risk factors such as hyperlipidemia,
hyperinsulinaemia, hypertension and obesity. Poor
glycaemic control manifests in costly, lifelong
morbidities, including blindness, kidney failure,
amputations and cardiovascular diseases. The
economic burden of treating long-term diabetes
complications is well documented (Hogan, 2002;
Wagner, 2001).
The involvement of community pharmacists in the
management of the diabetes patient has been shown to
be beneficial to the patient outcomes (Cranor, 2003).
The expertise of the pharmacist in monitoring
therapeutic outcomes in chronic diseases such as
diabetes is under-utilized. In Malaysia, patients are not
routinely referred to the community pharmacists for
therapeutic monitoring, counseling and education as
pharmacists are still not widely recognized as part of a
multi-disciplined healthcare team.
The aim of this study was to assess short-term
clinical outcomes of diabetes patients being provided
with a diabetic care program by a dedicated community
pharmacist in a community pharmacist set-up. It may
be used as ground work to start a pharmacist-managed
diabetes care clinic in the polyclinics or government
Study Design and Setting
This was a prospective study, using a single-group, prepost design from systemic randomly selected outpatients (sixty seven patients who met the inclusion
criteria and were willing to participate in this study) from
2 Government Polyclinics in Kuala Lumpur. These
patients agreed to participate in this program
voluntarily. They were followed up with 4 visits within a
period of 3 months at the study site which was a
community pharmacy. On their monthly visits, a
specially designed diabetes managed care program for
the community pharmacy was adhered to. Ethical
clearance was made by Ministry of Health Malaysia
(NIH) and Clinical Research Committee (CRC).
Participants were informed about the aims and
objectives of the study, its contents and consented to
the study (written consent).
The inclusion criteria for the participants were:
i. Patients with Type II Diabetes Mellitus currently on
oral hypoglycaemic agents with or without insulin
ii. Age group 40 – 64 years old
iii. Men and women, irrespective of their race
Iv Current levels of HbA1C > 6.5 % or FBS > 8 mmol/L
or PP-2 hours > 10.0mmol/L (based on patient’s
diabetic record book)
iv. May also have other cardiovascular risk factors
A secluded corner at the dispensing counter was
used for the individualized diabetes education and
counseling, clinical measurements, monitoring and
pharmacotherapy assessment
Program Contents
The programs of the visits were as listed below:
i. The patient’s profile which included personal data,
medical history and current medication (based on the
green record book that was given to diabetes patients
from the polyclinic) was taken.
ii. A patient’s visits record was created for the patient
for the documentation of all the visits and parameters
monitored for the duration of this study.
iii. Clinical measurements for the HbA1c, post prandial
2 hours blood glucose, total cholesterol, blood pressure
reading, body weight, body mass index and waist
circumference were done by the pharmacist..
iv. A series of related questions to assess the patient’s
general awareness, understanding and knowledge of
diabetes was asked.
v. Counseling on topics such as understanding
diabetes, preventing complications, importance of
timings of dosing and compliance, importance of blood
glucose monitoring, understanding the difference
between the HbA1c, fasting and post-prandial glucose
levels was given to the patient during the monthly visits.
vi. A daily dietary record form was given to the
patients to have them record their daily food intake for
at least 3 different days and this was evaluated by the
pharmacist. Other nutritional and dietary advice based
on the Medicinal Nutritional Therapy Guidelines were
vii. Cardiovascular risk factors associated with
diabetes such as high blood pressure, hyperlipidemia
and obesity were explained and their significance and
target levels emphasized.
viii. Weight management was emphasized based on
the weight, body mass index and waist circumference
measurements taken at every visit. This was with
reference to the Malaysian Clinical Practice Guidelines
on the Management of Obesity 2004.
ix. Evaluation of lifestyle behaviors such as smoking,
alcohol intake and physical activities was done and
changes were recommended accordingly based on the
Malaysian Clinical Practice Guidelines on the
Management of Type 2 Diabetes Mellitus 2004.
Lee et al. 035
Table 1: Distribution of patients based on ethnicity
Initial (%) n=47
23 (49)
16 (34)
8 (17)
X A compliance measurement interview questionnaire
described by (Morisky, 1986) was conducted once
during the first visit and repeated on the final visit.
There were
4 questions that were asked in this questionnaire. For
every “yes”, 1 point was allocated and zero points for a
“no”. The total score was a maximum of 4 points.
Higher scores would indicate poor compliance whereas
lower scores, better compliance
xi. The participants were asked to fill up a patient
awareness and satisfaction questionnaire at the end of
the study. They were given a choice to complete it on
the spot after the end of the final visit or they could take
it home to fill it up. The results were judged by a 5-point
Likert scale type (Strongly Agree- 4 points, Agree- 3
points, Undecided- 2 points, Disagree- 1 point, Strongly
Disagree- 0 point). Assessment was done on the
consensus of individual questions as well as the overall
survey. The higher the score, the more satisfied they
were about the program. The survey also solicited freeresponse feedback.
Dropout (%) n=17
12 (70)
3 (18)
2 (12)
Final (%) n=30
11 (37)
13 (43)
6 (20)
Values outside the range are reported as less than 2.5
or greater than 14.0.
ii. Optium Xceed Diabetes Monitoring System (Abbott
Medisense) – measured the post prandial blood
glucose. Measurement range was from 1.1 mmol/L –
27.8mmol/L. The test results are calibrated close to the
plasma blood samples.
iii. Omron HEM 907 Digital Automatic Blood Pressure
Monitor– measured the blood pressure by the
oscillometric method. Measurement range was from 0 –
299 mmHg; accuracy is within ± 4 mmHg.
iv. Accutrend GCT (Roche Diagnostics) – measured
the total cholesterol levels by the reflection photometry
method. Measurement range was from 3.88 mmol/L –
7.76 mmol/L.
v. Omron Karada Scan – measured the body weight
and calculated Body Mass Index. Measurement range
was from 0 – 135 kg.
vi. Waist circumference was taken with a measuring
tape measured to the nearest 0.1cm. It was taken
midway between the inferior margin of the last rib and
the crest of the ilium in a horizontal plane (WHO 1995).
Clinical Data Collection
Data Analysis and Statistical Methods
For the first visit, a baseline level of HbA1c and total
cholesterol levels were taken. Measurements of these
two parameters were taken again on the fourth and final
Also on the first and every other subsequent visit, 2
hour post prandial blood glucose levels, blood pressure
measurements, body weight, body mass index and
waist circumference were taken. This served as a guide
to the progress of the patient and to further encourage
and motivate the patient on his participation in
managing his diabetes. All the clinical measurements:
the HbA1c, post prandial 2 hours blood glucose, total
cholesterol and blood pressure were done by the
pharmacist. Measurement of body weight, body mass
index and waist circumference were taken by the
pharmacy assistants.
The instruments or diagnostic tools used for
measurements of the outcome parameters were:
i. DCA 2000+ Analyzer (Bayer) which measured the
HbA1c levels. The test linearity ranges from 2.5-14.0.
The data were analyzed using SPSS version 12.0.
Numeric data were expressed as mean ± SD or SEM
depending on the barriers. Paired T-test was conducted
to compare paired data with a significance level of p <
0.05. The statistical significance was performed with
median and mean variables, 95 % confidence interval
and odd ratios.
Patient Demographics and Characteristics
Of the 67 patients that consented and signed up to
participate in the study, only 46 of them turned out for
the initial visit. Drop-out of patients at follow-ups
resulted in 30 patients remaining at the end of the
study of which 27 came for 4 visits, 2 came for 3
visits and 1 patient for 2 visits. As such, all the data
that were analyzed will be based on these 30 patients
who completed the 3 months study period. Of the 30
patients, there were 17 males (56.7 %) and 13 females
Int. Res. J. Pharm. Pharmacol. 036
DM, 6, 20%
14, 46%
DM & HPT, 8, 27%
DM & HLD, 2, 7%
Figure 1 Pattern of Co-Morbidities DM – Diabetes Mellitus, HPT –
Hypertension, HLD – Hyperlipidemia
Table 2: Clinical Measures for Mean Scores and Standard Deviations (n=30)
Pair 1
Pair 2
Pair 3
Pair 4
Pair 5
Pair 6
Pair 7
Pair 8
HbA1c PRE %
HbA1c POST %
PP 2-HRS PRE (mmol/L)
PP- 2-HRS POST (mmol/L)
TC PRE (mmol/L)
TC POST (mmol/L)
DBP PRE (mmHg)
BMI PRE kg/m2
BMI POST kg/m2
WST PRE (cm)
Std. Deviation
Std. Error Mean
PP-2 = Post prandial 2 hours; TC = total cholesterol; SBP = systolic blood pressure; DBP = diastolic blood pressure; WT = weight;
BMI = body mass index; WST = waist circumference
(43.3 %). The mean age of the participants was 54.8 ±
5.6 years old. The minimum age was 44 years while the
maximum was 64 years. The average age for the
female participants was slightly higher at 55.0 ± 5.7
years as compared to the male participants which was
54.6 ± 5.7. (Table 1)
been diagnosed with diabetes mellitus, 3 (10 %)
patients have diabetes for less than a year, 18 (60 %)
patients have diabetes for between 1 to 5 years, 7 (23.3
%) patients have diabetes for 5 – 10 years and only 2
(6.7 %) patients have diabetes for more than 10 years.
Pattern of Co-Morbidity
History of Diabetes Mellitus
As for the breakdown of the number of years of having
The breakdown of co-morbidities of the patients is
summarized in Figure 1. In short, more than 80 % of
Lee et al. 037
Table 3: Paired Samples Test for Clinical Outcome Measures
Paired Differences
Pair 1
HbA1c pre % HbA1c post %
Pair 2
PP 2- pre –
PP 2post
Pair 3
Pair 4
Pair 5
Std. Error
95% Confidence Interval
of the Difference
TC pre –
TC post (mmol/L)
SBP pre –
SBP post (mmHg)
DBP pre –
Pair 6
WT in pre –
WT in post (kg)
Pair 7
BMI pre –
BMI post kg/m2
Pair 8
WST pre –
WST post (cm)
the patients had more than one co-morbidity besides
diabetes mellitus.
(2004), the summary of comparisons between outcome
measures and target values are shown in Table 4.
adherence and intervention for the patients is presented
in Figure 3.
Pattern of Prescribed Anti-Diabetic Agents
The patients were prescribed an average of 1.97 oral
hypoglycemic agents (OHAs) and/or insulin per patient.
The common OHAs used were glibenclamide,
gliclazide, metformin and acarbose. Only 1 patient was
prescribed with insulin (Mixtard). 10 patients (33.3 %)
were on 1 OHA, 12 patients (40 %) on 2 OHAs, 7
patients (23.3 %) on 3 OHAs and 1 patient (3.3 %) was
on 4 OHAs. It must be noted that the 4th OHA
(rosiglitazone) for this patient was added on by a
private physician that this patient was also seeing
Clinical outcomes
A summary of the results of the clinical measures and
its statistics is presented in Table 2 and Table 3. Based
on the Clinical Practice Guidelines for Diabetes Mellitus
Compliance interview questionnaire analysis
The mean compliance score was 2.13 ± 0.90 at
baseline and 1.63 ± 0.96 at the study end. The mean
score for difference between the pre and post results
was 0.5 ± 0.82 (p < 0.002).
Patients’ satisfaction and feedback survey
The maximum points that can be scored by each
patient were 44 points and minimum 0 point. The mean
value for the overall satisfaction of the patients towards
this program was 39.2 ± 4.6. The minimum score was
29 points while the maximum score was 44 points. This
would translate to an 89 % patient satisfaction rate for
this diabetes management program.
Int. Res. J. Pharm. Pharmacol. 038
Table 4
Summary of patients achieving target values and lifestyle changes
Baseline ( %)
Study end
n=30 (%)
HbA1c %
1 (3.3)
4 (13.3)
Post prandial 2 hours
< 8.0 mmol/L
3 (10)
12 (40)
Blood Pressure
< 130/80 mmHg
9 (30)
13 (43.3)
Total Cholesterol
< 4.5 mmol/L
12 (40)
15 (50)
Waist circumference
< 90 cm for men
< 80 cm for women
3 (10)
4 (13.3)
Body Mass Index
≤ 22.9 kg/m
1 (3.3)
9 (30)
5 ( 16.7)
4 (13.3)
2 (6.7)
3 (10)
Target values*
Taking other medication
4 (13.3%)
Taking health supplements
19 (63.3%)
Seek alternative/complemetary treatment
3 (10%)
Have received diabetic counselling
Aware of a least one complication of DM
5 (16.7%)
28 (93.3%)
Know how to avoid complications
19 (63.3%)
Knows at least one symptoms of hypoglycaemia
12 (40%)
Knows at least one symptoms of hyperglycaemia
9 (30%)
Knows importance of blood glucose monitoring
26 (86.7%)
Figure 3 Analysis of therapy adherence and intervention
Frequency, n
Lee et al. 039
Prescribing/dispensing error detected
5 (16.7%)
Dosing intervals and time adjusted
13 (43.3%)
Were given referral letters for change
in therapy
3 (10%)
Did not take at least one medication at
the right time
30 (100%)
8 (26.7%)
Did not take at least one medication
the proper dosage
19 (63.3%)
Insufficient drug information
Frequency, n
Figure 3 Analysis of therapy adherence and intervention
Based on the 30 patients that followed through the
program for 3 months, a diabetes care program
managed by a community pharmacist has shown
significant reductions in the HbA1c levels, total
cholesterol levels, systolic and diastolic blood
pressure and post prandial blood glucose levels. The
results are consistent and similar to the numerous
studies done in other pharmacist-managed diabetic
clinics in
ambulatory and community pharmacy models when
pharmacists are involved in the care of patients with
diabetes. The similar findings also obtained by various
workers (Shane-McWhorter 2005; Garrett 2005; Leal
2004; Morello 2006; Cioffi, 2004; Cranor, 2003).
The mean reduction of 1.2 % for the value of HbA1c
at the study end (baseline 9.1 ± 1.7 %, study end 7.9
± 1.6) would translate into the reduction of diabetic
related complications. A 1 % decrease in serum
HbA1c corresponds to a significant decreased risk of
complications. This includes 43% reduction in
amputation or fatal peripheral blood vessel disease,
37 % reduction in microvascular complications eg
kidney disease and blindness, 21 % reduction in all
The summary of the findings of the patients’
healthcare practices and awareness is presented in
Figure 2. The summary of the analysis of therap
related to diabetes, 14% reduction in heart attacks and
12 % reduction in strokes (Stratton, 2000).Even so, the
Western Pacific Declaration on Diabetes 2005 states that
all improvements or reductions are beneficial, whether or
not a target is reached.
Significant reductions in the HbA1c and post prandial
2 hours blood glucose levels as well as the other
measured outcomes such as the total cholesterol,
systolic and diastolic blood pressure is most likely due
to better compliance and adherence to therapy by the
patients. The patients have a better understanding of
their disease and know the importance of maintaining
their blood glucose levels to target to avoid
complications. They have also made some lifestyle
and dietary modifications such as increasing their
physical activity to at least 150 min/week, reducing
Carbohydrates such as rice, sugar, white bread
and increasing complex carbohydrates such as whole
grains, fruits, legumes and nuts. Low glycaemic index
foods were suggested and certain food substitutions
were recommended. They were asked to modify their
eating habits such as eating more frequent meals
with smaller portions and avoiding high calorie
As for the patient’s healthcare practices and
awareness, there were 4 patients (13.3 %) who were
taking additional medications besides the ones
prescribed at the polyclinic. The reasons were due
to unavailability of the medication that was previously
prescribed by the private doctor at the polyclinic.
There was one patient who actually added on an antihypertensive drug due to the recommendation from
his friend. He was advised appropriately about the
dangers of his action. Health supplements and herbal
remedies were also taken by19 patients (63.3 %). An
observation among the patients’ belief is that herbal
remedies are safe and better to take in the long term
as they do not have any side effects, whereas
allopathic medicine will damage their liver and kidneys
in the long run. Alternative/complementary therapy
was also sought by 3 patients (10 %). The reason was
that they wanted to try to cure their diabetes whereby
allopathic treatment only controls the disease.
It is a known fact that although the number of patie-
Int. Res. J. Pharm. Pharmacol. 040
with diabetes is increasing at a staggering rate, only
about one third of patients receive diabetes education
(Harris 1996). In this study, only 5 patients (16.7 %)
had received some diabetes education but without
any follow-ups. In the course of this study,
reinforcement of compliance and adherence to
therapy was given to the patient at every visit as it
was observed that the patient could not retain
everything at initial visits. As such, a diabetes
management program with routine follow-ups is
important to ensure adherence and motivation in the
maintenance of glycaemic control. The Compliance
Score based on the interview questionnaire was
significantly reduced, indicating better compliance to
therapy by the patients. Based on the awareness and
knowledge feedback, most of them who had
voluntarily omitted their medications or reduced their
dosages earlier were now taking their medications as
directed again. With the counseling given by the
pharmacist on adjustment of dosage times and ways
to reduce the side effects of the medications, the
patients’ drug tolerability and willingness to continue
with “problematic” drugs were contributive in the
overall improvement in their therapy adherence.
Based on the survey feedback analysis nearly all of
the patients were agreeable that their understanding
about diabetes in general has increased since joining
the program. All participants agreed that they are
more aware about the importance of medication
compliance and dosing times since joining the
program. Fairly all agreed that they are more
conscious about the food that they eat and those they
make an effort to avoid foods that may affect their
blood glucose. 96.7 % have made an effort to start
exercising or have increased or maintained the
frequency of exercise. All of them agreed that they are
more aware about the complications of diabetes that
they may encounter if they do not control their blood
glucose levels. Similarly all of them agreed that they
are satisfied with the counseling, advice and guidance
that they have received from the pharmacist. But 96.7
% found it easy to confide in the pharmacist about the
obstacles that they face in controlling their blood
glucose levels. 93.4% agreed that if they had not
participated in this program, they would not be
motivated to improve their uncontrolled or high
glucose levels. Again all participants agreed that a
diabetic program managed by pharmacists like this is
beneficial to help create more awareness to diabetics
like them. Nearly all agreed that a community set-up
like this is appropriate to conduct a program like this.
Again nearly all (96.7 %) agreed that they are
determined to maintain the changes that they have
made for the past 3 months after this study program is
The overall patient satisfaction score of is a valuab-
le indication that the patients were satisfied with this
diabetic management care program. In short,
community pharmacist has made an impact on the
patients to attain a high score like this.
From the interaction and communication between
the pharmacist and the patient, some of the
were that they felt that there is no proper follow-up at
the polyclinics as they were seen by different doctors
at every visit. They were not told much about their
conditions by their doctors, thus did not know exactly
what to do to control their diabetes.
The patient’s tolerability to the medications (side
effects) was not asked. Language is a barrier to some
of the Chinese patients as they do not understand the
doctor’s instruction in Malay.
They do not get proper guidance as to how to lower
their blood glucose levels when their blood glucose is
high. Instead they get scolded or accused of eating
excessively. Also, proper instructions on the dosage
timings of the diabetic medications in relation to meal
times were not given clearly.
This study has demonstrated that community
pharmacists can provide and conduct effective
diabetic management programs with significant
clinical outcome measures. Significant decrease in
HbA1c translates to the reduction in the risk of
diabetic complications. Significant reductions in total
cholesterol and blood pressure were also relevant in
the reduction of cardiovascular risk factors. The
community pharmacist has also managed to influence
more of the patients to start exercising
consistently. This study has also shown that the
patients’ compliance and adherence to therapy
improved after following this program for 3 months.
Based on the participants’ feedback survey, they were
very satisfied with the program and would like to see it
as a regular and continuing program to benefit more
diabetics like them
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